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Key value for chemical safety assessment

Effects on fertility

Description of key information

Read Across approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source subtance Solvent Blue 98:

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat , M/F, OECD guideline 422, GLP

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX
Reason / purpose for cross-reference:
read-across source
Clinical signs:
no effects observed
Dermal irritation (if dermal study):
no effects observed
Mortality:
mortality observed, non-treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, non-treatment-related
Urinalysis findings:
no effects observed
Behaviour (functional findings):
effects observed, non-treatment-related
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not examined
Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed
Key result
Dose descriptor:
LOAEL
Effect level:
100 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
histopathology: non-neoplastic
Key result
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
histopathology: non-neoplastic
Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effects on reproductive parameters
Key result
Reproductive effects observed:
no
Conclusions:
Based on read across to an analogue substance, The value of NOAEL (No Observed Adverse Effect Level) for reproduction and development for Solvent Blue 79B was predicted to be 1000mg/kg body weight per day. This was the highest dose given in an OECD 422 study conducted on the analogue source substance Solvent Blue 98. There were no treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring. The Target subtance Solvent Blue 79B is expected to have the same properties as the tested analogue substance Solvent Blue 98.
Executive summary:

A read across approach was used to evaluate potential toxicity effects of Solvent Blue 79B following repeated oral exposure

( Reaction mass of Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and1-[(2-ethylhexyl)amino]-4-(3-[(2-ethylhexyl)oxy]propylamino)anthraquinone and 1,4 di (3-[(2-ethylhexyl)oxy]propylamino) anthraquinone

An analogue substance Solvent Blue 98 was tested according to OECD guideline 422. The analogue substance is compositionally very similar. It is also anthraquinone based, with aliphatic amine substitutions.

Where the Solvent Blue 79B contains ethylhexyl amine groups and ethylhexyl)oxy]propylamino groups, the

Solvent Blue 98 contains ethylhexyl, methyl and pentyl groups. There is therefore overlap in the compositions and the structures are very similar. Further supporting information on the readacross approach has been provided in section 13 (Read across justification document)

Based on read across to an analogue substance, Solvent Blue 79B is not expected to cause any treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring.

The analogue substance results relevent to reproductive toxicity are summarised below:

There were no treatment-related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring in any treated groups compared to controls.


Limited gross pathological observations on postpartum day 4 pups revealed blue adipose tissue and stomach contents in pups from all treated groups.  This discoloration was attributed to the dye nature of the test material and demonstrated systemic exposure to the pups via the milk. 

The NOAEL for reproductive toxicity or for effects on prenatal/neonatal growth and survival was 1000 mg/kg/day, the highest dose level tested.


Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
good
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

In an OECD 422 study on the read across analogue subtance Solvent Blue 98, there were no treatment related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival. Based on similarity in compostion and structure, Solvent Blue 79B would be expected to produce similar results. The NOEL for reproductive toxicity was 1000mg/kg bw.

Therefore the criteria for classification are not met.

Additional information

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